Cal. Code Regs. Tit. 9, § 10000 - Definitions

(a) The following definitions shall apply to terminology contained in Chapter 4, Division 4, Title 9, California Code of Regulations.

(1) Amendment. "Amendment" means written changes in the protocol.

(2) Buprenorphine. "Buprenorphine" means a semisynthetic narcotic analgesic that is derived from thebaine and is administered in the form of its hydrochloride C₂₉H₄₁NO₄ · HCl to control moderate to severe pain and treat opioid dependence.

(3) Buprenorphine Products. "Buprenorphine products" means buprenorphine combination products approved by the FDA for maintenance treatment or detoxification of opioid dependence.

(4) DEA. "DEA" means the United States Drug Enforcement Administration.

(5) Department. "Department" means the Department of Health Care Services.

(6) Detoxification Treatment. "Detoxification treatment" means the treatment modality whereby replacement narcotic therapy is used in decreasing, medically determined dosage levels for a period not more than 21 days to treat physical dependence, while the patient is provided a comprehensive range of treatment services.

(7) FDA. "FDA" means the United States Food and Drug Administration.

(8) Illicit Drug. "Illicit drug" means any substance defined as a drug in Section 11014, Chapter 1, Division 10 of the Health and Safety Code, except:

(A) Drugs or medications prescribed by a physician or other person authorized to prescribe drugs, pursuant to Section 4040, Chapter 9, Division 2 of the Business and Professions Code, and used in the dosage and frequency prescribed; or

(B) Over-the-counter drugs or medications used in the dosage and frequency described on the box, bottle, or package insert.

(9) Laboratory. "Laboratory" means a drug analysis laboratory approved and licensed by the California Department of Public Health to test or analyze samples of patient body specimens for the substances named in Section 10315 for a narcotic treatment program.

(10) Levoalphacetylmethadol (LAAM). "Levoalphacetylmethadol (LAAM)," also known as Levo-Alpha-Acetyl-Methadol or levomethadyl acetate hydrochloride, means the substance that can be described chemically as levo-alpha-6-dimethylamino-4, 4-diphenyl-3-heptyl acetate hydrochloride.

(11) License. "License" means a written permit issued by the Department to operate a narcotic treatment program in the State of California.

(12) Licensing Action. "Licensing action" means any administrative action taken by the Department that would adversely affect the license of a narcotic treatment program, including:

(A) Denial of an application for a license;

(B) Denial of a protocol amendment;

(C) Denial of a supplemental written protocol for a medication unit;

(D) Denial of a supplemental written protocol for an OBNTN;

(E) Denial of a request for license renewal;

(F) Denial of a request to relocate a narcotic treatment program outside of its current county;

(G) Assessment of a civil penalty; or

(H) Suspension or revocation of a license.

(13) Maintenance Treatment. "Maintenance treatment" means the treatment modality whereby replacement narcotic therapy is used in sustained, stable, medically determined dosage levels for a period in excess of 21 days to treat opioid addiction, while the patient is provided a comprehensive range of treatment services.

(14) Medical Director. "Medical director" means the physician licensed to practice medicine in California who is responsible for medical services provided by the program.

(15) Medication. "Medication" means any opioid agonist medications that have been approved for use in replacement narcotic therapy, including:

(A) Methadone;

(B) Levoalphacetylmethadol (LAAM);

(C) Buprenorphine and buprenorphine products approved by the FDA for maintenance treatment or detoxification treatment of opioid addiction; and

(D) Any other medication approved by the FDA for the purpose of narcotic replacement treatment or medication-assisted treatment of substance use disorders.

(16) Medication Unit. "Medication unit" means a facility established as part of, but geographically separate from, a narcotic treatment program, from which licensed private practitioners or community pharmacists dispense or administer an opioid agonist treatment medication or collect samples for drug testing or analysis.

(17) Methadone. "Methadone" means the substance that can be described as 6-dimenthylamino-4, 4-diphenyl-3-heptanone. Methadone doses are usually administered as methadone hydrochloride.

(18) Narcotic Drug. "Narcotic drug" means any controlled substance which produces insensibility or stupor and applies especially to opium or any of its natural derivatives or synthetic substitutes.

(19) Narcotic Treatment Program (NTP). "Narcotic treatment program (NTP)" means a licensed opioid addiction treatment program, whether inpatient or outpatient, which offers all of the following: evaluation, maintenance treatment and/or detoxification treatment, and other services in conjunction with replacement narcotic therapy.

(20) Office-Based Narcotic Treatment Network (OBNTN). "Office-Based Narcotic Treatment Network (OBNTN)" means a network of providers that are affiliated and associated with a primary narcotic treatment program, offering one or more of the following: evaluation of medical, employment, alcohol, criminal, and psychological problems; screening for diseases that are disproportionately represented in the substance use disorder population; counseling by addiction counselors who are evaluated through ongoing supervision; and professional medical, social work, and mental health services, on-site or by referral.

(21) Opiate. "Opiate" means one of a group of alkaloids derived from the opium poppy (Papaver somniferum), with the ability to induce analgesia, euphoria, and, in higher doses, stupor, coma, and respiratory depression. The term excludes synthetic opioids.

(22) Opioid. "Opioid" means any psychoactive chemical that resembles morphine in pharmacological effects, including opiates and synthetic/semisynthetic agents that exert their effects by binding to highly selective receptors in the brain where morphine and endogenous opioids affect their actions.

(23) Opioid Addiction. "Opioid Addiction," and the related term "addiction to opioids," mean a condition characterized by compulsion and lack of control that lead to illicit or inappropriate opioid-seeking behavior, including an opioid addiction that was acquired or supported by the misuse of a physician's legally prescribed narcotic medication.

(24) Physical Dependence. "Physical Dependence," and related terms "dependence," "dependency," "dependent," and "physiological dependence," means a condition resulting from repeated administration of a drug that necessitates its continued use to prevent withdrawal syndrome that occurs when the drug is abruptly discontinued.

(25) Primary Metabolite of Methadone. "Primary metabolite of methadone" means 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine.

(26) Primary Narcotic Treatment Program. "Primary Narcotic Treatment Program" means a program with an affiliated and associated medication unit and/or OBNTN.

(27) Program. "Program" means a narcotic treatment program.

(28) Program Director. "Program director" means the person who has primary administrative responsibility for operation of an approved and licensed program.

(29) Program Sponsor. "Program sponsor" means the person or organization named in the Initial Application Coversheet form DHCS 5014 (04/16), herein incorporated by reference, as responsible for the operation of the narcotic treatment program and who assumes responsibility for all of its employees, including any practitioners, agents, or other persons providing medical, rehabilitative, or counseling services at the program or any of its medication units and OBNTNs. The program sponsor need not be a licensed physician but shall employ a licensed physician for the position of medical director.

(30) Protocol. "Protocol" means a written document, including required forms, which sets forth a program's treatment concept, organization, and operational procedures.

(31) Rationale. "Rationale" means a rational statement of principles or the logical basis for a procedure.

(32) Replacement Narcotic Therapy. "Replacement narcotic therapy" means Medication-assisted treatment that uses agonist or partial agonist medication to normalize brain chemistry, block the euphoric effects of opioids and relieve physiological cravings and normalize body functions.

(33) SAMHSA. "SAMHSA" means the Substance Abuse and Mental Health Services Administration.

(34) Treatment. "Treatment" means services which will habilitate and rehabilitate patients with an opioid addiction to a basic level of social, life, work, and health capabilities that help them become productive, independent members of society and will include:

(A) Replacement narcotic therapy;

(B) Evaluation of medical, employment, alcohol, criminal, and psychological problems;

(C) Screening for diseases that are disproportionately represented in the substance use disorder population;

(D) Monitoring for illicit drug use;

(E) Counseling by addiction counselors that are evaluated through ongoing supervision; and

(F) Professional medical, social work, and mental health services, on-site or by referral (through contracted interagency agreements).

Notes

Cal. Code Regs. Tit. 9, § 10000

1. New subchapter 4 (articles 1-22, sections 9995-10340, not consecutive) filed 9-1-83; effective upon filing pursuant to Government Code section 11346.2(d) (Register 83, No. 36). CROSS REFERENCE: title 9, chapter 1, subchapter 6, sections 1000-1311.
2. Change without regulatory effect renumbering and amending former section 9995 to section 10000 filed 6-3-91 pursuant to section 100, title 1, California Code of Regulations (Register 91, No. 34).
3. Amendment filed 3-15-96 as an emergency; operative 3-15-96 (Register 96, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-13-96 or emergency language will be repealed by operation of law on the following day.
4. Amendment refiled 7-8-96 as an emergency; operative 7-12-96 (Register 96, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-12-96 or emergency language will be repealed by operation of law on the following day.
5. Amendment refiled 10-23-96 as an emergency; operative 10-29-96 (Register 96, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-26-97 or emergency language will be repealed by operation of law on the following day.
6. Amendment refiled 2-11-97 as an emergency; operative 2-24-97 (Register 97, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-24-97 or emergency language will be repealed by operation of law on the following day.
7. Certificate of Compliance as to 2-11-97 order transmitted to OAL 3-4-97; disapproved by OAL and order of repeal as to 2-11-97 order filed 4-15-97 (Register 97, No. 16).
8. Amendment filed 4-15-97 as an emergency; operative 4-15-97 (Register 97, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-13-97 or emergency language will be repealed by operation of law on the following day.
9. Certificate of Compliance as to 4-15-97 order, including amendment of subsections (a)(2), (a)(4)(A), (a)(5), (a)(10), (a)(12), (a)(16) and (a)(17), transmitted to OAL 6-2-97 and filed 6-13-97 (Register 97, No. 24).
10. New subsection (a)(22) and subsection renumbering filed 6-29-98; operative 6-29-98 pursuant to Government Code section 11343.4(d) (Register 98, No. 27).
11. Change without regulatory effect amending NOTE filed 4-19-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 16).
12. Amendment of section and NOTE filed 5-7-2020; operative 7-1-2020 (Register 2020, No. 19).

Note: Authority cited: Sections 11750, 11755, 11835, 11839.3, 11839.6 and 11839.20, Health and Safety Code. Reference: Sections 11839.2, 11839.3, 11839.5, 11839.6, 11839.7 and 11839.19, Health and Safety Code.

1. New subchapter 4 (articles 1-22, sections 9995-10340, not consecutive) filed 9-1-83; effective upon filing pursuant to Government Code section 11346.2(d) (Register 83, No. 36). CROSS REFERENCE: title 9, chapter 1, subchapter 6, sections 1000-1311.
2. Change without regulatory effect renumbering and amending former section 9995 to section 10000 filed 6-3-91 pursuant to section 100, title 1, California Code of Regulations (Register 91, No. 34).
3. Amendment filed 3-15-96 as an emergency; operative 3-15-96 (Register 96, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-13-96 or emergency language will be repealed by operation of law on the following day.
4. Amendment refiled 7-8-96 as an emergency; operative 7-12-96 (Register 96, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-12-96 or emergency language will be repealed by operation of law on the following day.
5. Amendment refiled 10-23-96 as an emergency; operative 10-29-96 (Register 96, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-26-97 or emergency language will be repealed by operation of law on the following day.
6. Amendment refiled 2-11-97 as an emergency; operative 2-24-97 (Register 97, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-24-97 or emergency language will be repealed by operation of law on the following day.
7. Certificate of Compliance as to 2-11-97 order transmitted to OAL 3-4-97; disapproved by OAL and order of repeal as to 2-11-97 order filed 4-15-97 (Register 97, No. 16).
8. Amendment filed 4-15-97 as an emergency; operative 4-15-97 (Register 97, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-13-97 or emergency language will be repealed by operation of law on the following day.
9. Certificate of Compliance as to 4-15-97 order, including amendment of subsections (a)(2), (a)(4)(A), (a)(5), (a)(10), (a)(12), (a)(16) and (a)(17), transmitted to OAL 6-2-97 and filed 6-13-97 (Register 97, No. 24).
10. New subsection (a)(22) and subsection renumbering filed 6-29-98; operative 6-29-98 pursuant to Government Code section 11343.4(d) (Register 98, No. 27).
11. Change without regulatory effect amendingNote filed 4-19-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 16).
12. Amendment of section and Note filed 5-7-2020; operative 7/1/2020 (Register 2020, No. 19).